The Top 5: July 2016

1st August 2016 (Last Updated July 18th, 2018 09:22)

CTA highlights the best articles from the month of July 2016

The Top 5: July 2016

There were numerous articles in July 2016 that covered a wide range of topical issues. Here are five of the best stories you might have missed... (click the headline to finish reading the story)

The Brexit Fallout – One Month On

In the month since the UK decided to leave the EU, there have been seismic changes in the landscape of British politics. As David Cameron stepped down ignominiously, in stepped Theresa May, a safe pair of hands many feel could steady the ship in turbulent times.

But while there’s been a sea of change in Westminster, the UK pharma and medical device industries has looked on somewhat anxiously as it navigates its own way through choppy waters.

CTA recently caught up with Andrew Thompson, who's the Director of Therapy Research and Analysis, Medical Devices at GlobalData. In this compelling interview, Thompson explains that while there are obvious dangers to the UK leaving the EU, it might not be all doom and gloom…

Creating a Landscape for Patient Engagement

In May of this year, the US Food and Drug Administration (FDA) released a Guidance for Industry on group-level “Expanded Access” for unapproved drugs. Journalists and investors reacted with wide speculation as to what these “new rules” might mean for drug development. The answer is: not much; the rules are not new at all. Today's regulations on Expanded Access in the US have been the same since 2009, when two minor modifications were made (one relating to cost recovery, the other relating to distinct authorization criteria for intermediate size and large size group programs.) The FDA periodically issues ‘Guidance for Industry’ documents on various regulatory topics. They clarify existing rules, rather than set new ones. Furthermore, the recent Guidance on Expanded Access was released in its draft form in 2013, meaning those who are interested or already involved in the practice have had plenty of time to familiarize themselves with the information. But there is a lot more to Expanded Access than regulatory policy.

Clinical Trials in Asia: Tale of the Tiger or Tiger by the Tail? Part IIa – South Korea

As a group, the four Tier-2 Asian countries have a strong potential to be knocking on the door of the lone Tier-1 giant, Japan. The one common factor that has brought these countries this far is a strong government commitment and 360-degree vision to be competitive with the West. This aspiration to be on a par with Western standards of quality and good clinical practices has resulted in exponential improvements in facilities, infrastructure, human resources and streamlining of regulations.

From the perspective of both timelines and costs, biotech companies in the US and Europe would do well to consider an Asia-first clinical development strategy. In particular, for four therapeutic areas - Cancer, Heart disease, Diabetes, and Infectious Diseases - South Korea is an attractive place to start.

Monitoring the Integrity of Clinical Serology Data

As the number of clinical trials increase, the number of clinical specimens that need to be analyzed increases in kind. The ability to test this increased number of specimens within an organization is not always feasible due to internal capacity and resource limitations. Therefore, clinical testing activities tend to be outsourced to Contract Research Organizations (CROs). A Sponsor may transfer any or all of their trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data resides with the Sponsor. Additionally, the outsourcing of clinical serology testing adds another layer of separation between the activities required to generate clinical test data and the Sponsor's ability to ensure the generation of quality and consistent data. This situation makes monitoring the integrity of clinical test data generated at a CRO paramount.

Embracing Personal Connected Health as a novel way to managing patient generated data

Economical, effective and secure exchange of patient generated data is not only achievable, it is now a reality. The introduction of the Personal Connected Health Alliance now provides a proven set of guidelines ready for implementation by device manufacturers, health services developers and healthcare providers alike.

It was almost 10 years ago when a group of companies lead by Intel® got together to form the Continua Health Alliance. Their goal was to solve a problem that has impacted healthcare for many years: Interoperability. One can argue that the lack of interoperability of medical and healthcare devices has prevented or at least delayed major innovations that are second nature in the consumer space.  Everybody can take high quality pictures with his or her Smartphone and share those in seconds with anybody around the world; they can store it, print it, attach it, embed it, and even edit it. The founding members of Continua realized that more work needs to be done to ensure the transmission of health and wellness data is safe, secure and private while maintaining its integrity and consistency, especially under the aspect that data exchange involves multiple interfaces utilizing diverse technologies.